RecruitingPhase 3NCT07684235

Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-1-EXTENSION)

A Phase 3, Randomized, Double-Blind Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Participants With Obesity or Overweight


Sponsor

Amgen

Enrollment

3,200 participants

Start Date

Jul 23, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The primary objective of this trial is to evaluate the long-term efficacy, safety, and tolerability of maridebart cafraglutide in participants with obesity or overweight. Trial 20250197 is an extension of trial 20210181 (NCT06858839).


Eligibility

Min Age: 18 YearsMax Age: 99 Years

Inclusion Criteria6

  • Signed informed consent form (ICF) which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
  • Completed the parent trial (2010181)
  • Completed week 72 visit in parent trial
  • Did not permanently discontinue trial intervention in parent trial
  • Randomized within 7 Days of week 72 visit in the parent trial
  • Participants must use protocol-specified contraception during treatment, and for an additional 16 weeks after the last dose of trial intervention

Exclusion Criteria15

  • Planned (during the trial) surgical, endoscopic, or device-based treatment for obesity
  • Body mass index ≤ 18.5 kilograms per meter square (kg/m\^2)
  • Participant has known sensitivity to any of the products or components to be administered during dosing
  • History of ischemic optic neuropathy
  • Any malignancy diagnosed during parent trial (20210181) except for the following treated with curative intent: nonmelanoma skin cancers, breast ductal carcinoma in situ, cervical carcinoma in situ, or prostate cancer in situ.
  • Newly identified (i.e., identified during 20210181) multiple endocrine neoplasia syndrome type 2 or family (first-degree relative\[s\]) history of medullary thyroid cancer.
  • Patient Health Questionnaire-9 (PHQ-9) score of ≥ 15 at week 72 visit from parent trial before randomization
  • Any suicidal ideation of category 4 or 5 OR any suicidal behavior on the Columbia-Suicide Severity Rating Scale (C-SSRS) Since Last Visit version at week 72 visit from parent trial before randomization.
  • Participant unlikely to be able to complete all protocol-required procedures, restrictions and requirements, in the judgment of the individual and investigator.
  • History or evidence of any other clinically significant disorder, condition, or disease (including, but not limited to known drug or alcohol abuse, eating disorders, and conditions identified during the parent trial) that, in the opinion of the investigator, would pose a risk to participant safety.
  • Currently pregnant (confirmed with positive pregnancy test) or breastfeeding or
  • Planning to become pregnant or breastfeed while on trial until an additional 16 weeks after the last dose of trial intervention.
  • Major surgical procedures planned during the trial.
  • Participants with minor surgical procedures (not requiring general anesthesia or deep sedation) planned during the trial may be eligible at the discretion of the investigator.
  • Investigative site personnel directly affiliated with the trial and/or their immediate family (ie, spouse, parent, child, or sibling, whether biological or legally adopted).

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGMaridebart cafraglutide

Administered subcutaneously

DRUGPlacebo

Administered subcutaneously.


Locations(31)

Alliance For Multispecialty Research - Daphne

Daphne, Alabama, United States

Apex Clinical Research

San Diego, California, United States

Artemis Institute for Clinical Research

San Diego, California, United States

Diablo Clinical Research

Walnut Creek, California, United States

Chase Medical Research LLC

Waterbury, Connecticut, United States

Optimus U Corporation

Miami, Florida, United States

Research Institute of South Florida

Miami, Florida, United States

Clinical Neuroscience Solutions - Orlando

Orlando, Florida, United States

Florida Institute for Clinical Research

Orlando, Florida, United States

Flourish Research - Great Lakes Clinical Trials

Chicago, Illinois, United States

Velocity Clinical Research - Baton Rouge

Baton Rouge, Louisiana, United States

Headlands Research - Detroit

Southfield, Michigan, United States

Velocity Clinical Research- Binghamton

Binghamton, New York, United States

Rochester Clinical Research

Rochester, New York, United States

Carolina Research Center Inc

Shelby, North Carolina, United States

Clinical Trial Investigator Clinical Research Center

Cincinnati, Ohio, United States

Velocity Clinical Research - Cincinnati

Cincinnati, Ohio, United States

New Phase Research and Development

Knoxville, Tennessee, United States

Elligo Clinical Research Center

Austin, Texas, United States

Epic Medical Research - Red Oak

DeSoto, Texas, United States

Great Lakes Research Institute - McAllen Research

Pharr, Texas, United States

Clinical Trials of Texas

San Antonio, Texas, United States

Pantheon Clinical Research

Bountiful, Utah, United States

Chrysalis Clinical Research, LLC

St. George, Utah, United States

Health Research of Hampton Roads

Newport News, Virginia, United States

Allegiance Research Specialists

Wauwatosa, Wisconsin, United States

Canopy Clinical Sutherland

Miranda, New South Wales, Australia

Canopy Clinical Wollongong

Wollongong, New South Wales, Australia

Fusion Clinical Research

Norwood, South Australia, Australia

Emeritus Research Camberwell

Camberwell, Victoria, Australia

Canopy Clinical Altona North

North Altona, Victoria, Australia

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07684235


Related Trials